For Patients

Edluar (zolpidem tartrate) Sublingual Tablets is an imidazopyridine hypnotic used to treat insomnia. Common side effects of Edluar include sleepiness, dizziness, and mood or behavior changes.

The recommended dosage of Edluar is 10 mg once daily. Sodium oxybate may interact with Edluar. Do not drive, use machinery, or do other activity requiring full alertness after taking Edluar. If you are pregnant only take Edluar if the potential benefits outweigh the potential risk to the fetus. Exercise caution when taking Edluar while breastfeeding. Edluar may be habit forming and should only be used by the person it is prescribed for. Do not stop taking Edluar before first talking with your doctor as it may cause withdrawal symptoms.

Our Edluar (zolpidem tartrate) Sublingual Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Zolpidem may cause a severe allergic reaction. Stop taking zolpidem and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

SIDE EFFECTS: Dizziness or difficulty with coordination may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly. To reduce the risk of dizziness or falling, get up slowly when rising from a sitting or lying position.

This medication may make you sleepy during the day. Tell your doctor if you have daytime drowsiness. Your dose may need to be adjusted.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake ("sleep-driving"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. Your risk is increased if you use alcohol or other medications that can make you drowsy while taking zolpidem.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Clinical Trials Experience

Associated With Discontinuation Of Treatment

Approximately 4% of 1,701 patients who received zolpidem
tartrate at all doses (1.25 to 90 mg) in U.S. premarketing clinical trials
discontinued treatment because of an adverse reaction. Reactions most commonly
associated with discontinuation from U.S. trials were daytime drowsiness
(0.5%), dizziness (0.4%), headache (0.5%), nausea (0.6%), and vomiting (0.5%).

Approximately 4% of 1,959 patients who received zolpidem
tartrate at all doses (1 to 50 mg) in similar foreign trials discontinued
treatment because of an adverse reaction. Reactions most commonly associated
with discontinuation from these trials were daytime drowsiness (1.1%),
dizziness/vertigo (0.8%), amnesia (0.5%), nausea (0.5%), headache (0.4%), and
falls (0.4%).

Data from a clinical study in which selective serotonin reuptake inhibitor (SSRI)-treated patients were given zolpidem tartrate
revealed that four of the seven discontinuations during double-blind treatment
with zolpidem (n=95) were associated with impaired concentration, continuing or
aggravated depression, and manic reaction; one patient treated with placebo
(n=97) was discontinued after an attempted suicide.

Most Commonly Observed Adverse Reactions In Controlled Trials

During short-term treatment (up to 10 nights) with
zolpidem tartrate at doses up to 10 mg, the most commonly observed adverse
reactions associated with the use of zolpidem and seen at statistically
significant differences from placebo-treated patients were drowsiness (reported
by 2% of zolpidem patients), dizziness (1%), and diarrhea (1%). During
longer-term treatment (28 to 35 nights) with zolpidem tartrate at doses up to
10 mg, the most commonly observed adverse reactions associated with the use of
zolpidem and seen at statistically significant differences from placebo-treated
patients were dizziness (5%) and drugged feelings (3%).

Adverse Reactions Observed At An Incidence Of = 1% In Controlled Trials

The following tables enumerate treatment-emergent adverse
event frequencies that were observed at an incidence equal to 1% or greater
among patients with insomnia who received zolpidem tartrate and at a greater
incidence than placebo in U.S. placebo-controlled trials. Events reported by
investigators were classified utilizing a modified World Health Organization
(WHO) dictionary of preferred terms for the purpose of establishing event
frequencies. The prescriber should be aware that these figures cannot be used
to predict the incidence of side effects in the course of usual medical
practice, in which patient characteristics and other factors differ from those
that prevailed in these clinical trials. Similarly, the cited frequencies
cannot be compared with figures obtained from other clinical investigators
involving related drug products and uses, since each group of drug trials is
conducted under a different set of conditions. However, the cited figures
provide the physician with a basis for estimating the relative contribution of
drug and nondrug factors to the incidence of side effects in the population
studied.

The following table was derived from a pool of 11
placebo-controlled short-term U.S. efficacy trials involving zolpidem in doses
ranging from 1.25 to 20 mg. The table is limited to data from doses up to and
including 10 mg, the highest dose recommended for use.

*Reactions reported by at least
1 % of patients treated with oral zolpidem and at a greater frequency than
placebo.

The following table was derived
from a pool of three placebo-controlled long-term efficacy trials involving
oral zolpidem. These trials involved patients with chronic insomnia who were
treated for 28 to 35 nights with zolpidem at doses of 5, 10, or 15 mg. The
table is limited to data from doses up to and including 10 mg, the highest dose
recommended for use. The table includes only adverse events occurring at an
incidence of at least 1% for zolpidem patients.

*Reactions reported by at least
1% of patients treated with oral zolpidem and at a greater frequency than
placebo.

Dose Relationship For Adverse Reactions Associated With Oral Zolpidem

There is evidence from dose
comparison trials suggesting a dose relationship for many of the adverse
reactions associated with oral zolpidem use, particularly for certain CNS and
gastrointestinal adverse events.

Oral Tissue-Related Adverse Reactions To Edluar

The effect of chronic daily
administration of Edluar on oral tissue was evaluated in a 60-day open-label
study in 60 insomniac patients. One patient developed transient sublingual erythema, and another transient paresthesia of the tongue.

Zolpidem was administered to 3,660 subjects in clinical
trials throughout the U.S., Canada, and Europe. Treatment-emergent adverse
events associated with clinical trial participation were recorded by clinical
investigators using terminology of their own choosing. To provide a meaningful
estimate of the proportion of individuals experiencing treatment-emergent
adverse events, similar types of untoward events were grouped into a smaller
number of standardized event categories and classified utilizing a modified
World Health Organization (WHO) dictionary of preferred terms.

The frequencies presented, therefore, represent the
proportions of the 3,660 individuals exposed to zolpidem, at all doses, who
experienced an event of the type cited on at least one occasion while receiving
zolpidem. All reported treatment-emergent adverse events are included, except those
already listed in the table above of adverse events in placebo-controlled
studies, those coding terms that are so general as to be uninformative, and
those events where a drug cause was remote. It is important to emphasize that,
although the events reported did occur during treatment with zolpidem, they
were not necessarily caused by it.

Adverse events are further classified within body system
categories and enumerated in order of decreasing frequency using the following
definitions: frequent adverse events are defined as those occurring in greater
than 1/100 subjects; infrequent adverse events are those occurring in 1/100 to
1/1,000 patients; rare events are those occurring in less than 1/1,000
patients.